Adjuvant Therapy for High-Risk Intrahepatic Cholangiocarcinoma: A Real-World Study

A Real-World Study on Postoperative Adjuvant Therapy for Intrahepatic Cholangiocarcinoma Patients With High-Risk Recurrence Factors

This multicenter real-world study assesses the efficacy and safety of adjuvant therapies in postoperative intrahepatic cholangiocarcinoma (ICC) patients with high-risk recurrence factors.

90 eligible patients will be assigned to: Cohort 1: GP (gemcitabine/cisplatin) + adebrelimab Cohort 2: Apatinib + adebrelimab Cohort 3: S-1 (tegafur/gimeracil/oteracil) + adebrelimab Outcomes will be compared against historical real-world controls receiving standard chemotherapy.

Study Overview

• Status: Recruiting
• Conditions: Intrahepatic Cholangiocarcinoma (Icc)
• Intervention / Treatment: Drug: Adebrelimab; Drug: Gemcitabine; Drug: Cisplatin; Drug: Apatinib; Drug: S-1

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Baoluhe Zhang; Phone Number: 010-69152831; Email: dushd@pumch.cn

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking Union Medical College Hospital (PUMCH)
    • Contact: Baoluhe Zhang; Phone Number: 010-69152831; Email: dushd@pumch.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with intrahepatic cholangiocarcinoma (ICC) at high risk of recurrence

Description

Inclusion Criteria:

• Histologically confirmed ICC within 12 weeks after curative resection
• Any T stage; N0/N+; M0.
• At least one high-risk factor:

Preoperative tumor penetration of the liver capsule or extrahepatic direct invasion; Preoperative imaging showing multifocal lesions or a single lesion >5 cm; Vascular invasion (preoperative or postoperative pathology); Regional lymph node metastasis.

• No prior systemic therapy for ICC.
• ECOG performance status 0-2.
• Expected survival ≥3 months.
• Adequate organ function.
• Agreement to use effective contraception (or surgical sterilization) during the study and for 120 days after the last dose.
• Signed informed consent and anticipated good compliance with the study protocol.

Exclusion Criteria:

• Immunosuppressive therapy within 28 days prior to enrollment (excluding topical/inhaled corticosteroids or physiologic steroid doses ≤10 mg/day prednisone equivalent).
• Systemic anticancer herbs/immunomodulators (e.g., thymosin, interferons) within 4 weeks, except for pleural effusion control.
• Uncontrolled cardiovascular disease:

Unstable angina/myocardial infarction Arrhythmias with QTc ≥450 ms (men) or ≥470 ms (women) NYHA Class III-IV heart failure or LVEF <50%

• Active infections (IV antibiotics/antivirals required) or fever >38.5°C within 4 weeks; or major surgery within 3 weeks.
• Active autoimmune/immunodeficiency diseases (e.g., hepatitis, pneumonitis, rheumatoid arthritis), except:

Hypothyroidism on stable hormone replacement Type 1 diabetes with controlled glucose Uncontrolled asthma requiring systemic bronchodilators (resolved childhood asthma allowed).

- Active infections: HIV/AIDS

HBV (DNA ≥500 IU/mL) or HCV (RNA-positive) unless:

HBV DNA <500 IU/mL + antiviral therapy ≥14 days

• Prior/proposed organ transplantation (excluding corneal grafts).
• Concurrent interventional trials or investigational drugs within 4 weeks without recovery to Grade ≤1 toxicity.
• Hypersensitivity to study drug components.
• Allogeneic transplant history/plans.
• Uncontrolled psychiatric/substance abuse disorders.
• Refractory hypertension (≥140/90 mmHg despite treatment).
• Clinically significant bleeding/thromboembolism:

GI bleeding within 3 months Thrombotic events within 6 months (stroke, DVT/PE)

• Coagulopathy (INR >1.5, PT >ULN+4s, aPTT >1.5×ULN) or anticoagulant use.
• Proteinuria ≥++ on dipstick or 24-h urine protein ≥1 g.
• Other high-risk conditions per investigator judgment.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1: GP + adebrelimab	Drug: Adebrelimab; Adebrelimab administered intravenously at [1200mg] on day 1 of each 21-day cycle, for up to 17 cycles, common to all three cohorts.; Drug: Gemcitabine; Gemcitabine administered intravenously at [1000 mg/m^2] on days 1 and 8 of each [21]-day cycle, for up to 8 cycles, in combination with cisplatin and adebrelimab，; Drug: Cisplatin; Cisplatin administered intravenously at [25 mg/m^2] on days 1 and 8 of each [21]-day cycle, for up to 8 cycles, in combination with gemcitabine and adebrelimab.
Cohort 2: Apatinib + adebrelimab	Drug: Adebrelimab; Adebrelimab administered intravenously at [1200mg] on day 1 of each 21-day cycle, for up to 17 cycles, common to all three cohorts.; Drug: Apatinib; Apatinib administered orally at [250mg] once daily continuously, for up to 17 cycles, in combination with adebrelimab.
Cohort 3: S-1 + adebrelimab	Drug: Adebrelimab; Adebrelimab administered intravenously at [1200mg] on day 1 of each 21-day cycle, for up to 17 cycles, common to all three cohorts.; Drug: S-1; S-1 (tegafur/gimeracil/oteracil) administered orally twice daily on days 1-14 of each 21-day cycle, dosed according to body surface area, for up to 8 cycles, in combination with adebrelimab.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Recurrence-Free Survival (RFS)	Through study completion, an average of 4 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall Survival (OS)	Through study completion, an average of 4 years

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Shunda Du, Peking Union Medical College Hospital (PUMCH); Principal Investigator: Mei Guan, Peking Union Medical College Hospital (PUMCH)

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: May 26, 2025
• First Submitted That Met QC Criteria: June 5, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Cholangiocarcinoma; Cirrhosis, Familial, with Pulmonary Hypertension; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Platinum Compounds; Gemcitabine; Cisplatin; apatinib; S 1 (combination)
• Other Study ID Numbers: I-25PJ1046